Duns Number:020275145
Device Description: Chart, X-Ref Ohio Med 617-0020-300, 5" x 200', 8L
Catalog Number
139200
Brand Name
Chart, X-Ref Ohio Med 617-0020-300, 5" x 200', 8L
Version/Model Number
Chart, X-Ref Ohio Med 617-0020-300 - 139200
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DSF
Product Code Name
Recorder, Paper Chart
Public Device Record Key
95177275-cac6-4a52-8e74-e2163182cf65
Public Version Date
March 31, 2020
Public Version Number
1
DI Record Publish Date
March 23, 2020
Package DI Number
00817081025651
Quantity per Package
1
Contains DI Package
00817081025644
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Roll
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 222 |
2 | A medical device with a moderate to high risk that requires special controls. | 126 |